FDA Meeting – Essure

My name is Cindy Pearson, and I am the Executive Director of The National Women’s Health Network. The National Women’s Health Network is a nonprofit advocacy organization that works to improve the health of all women. We are supported by our members and do not accept financial support from drug companies or medical device manufacturers. We bring the voices, concerns and needs of women consumers to policy and regulatory tables.

Since the Network’s founding 40 years ago, we have brought the voices of women to the FDA, advocating for medical products that meet women’s real life needs and a drug and medical device development process that reflects women’s lived experiences.

In 2002, we testified at the FDA in support of the approval of the Essure device. As we stated back then, expanding the number of safe and effective contraceptive methods available would be a significant advance for women’s health. We commented on women’s need to be able to use this method of sterilization safely, effectively, and with long term satisfaction. We also acknowledged that at that time there was not very much data available on the device; it had been tested in a relatively small number of women and not for very long. At the 2002 meeting, we advocated for the use of a written consent procedure to improve the likelihood that women and their clinicians will engage in the full discussion necessary to achieve informed choice. We continue to stand by those statements today.

In 2002, we also commented on the importance of providing information on the risks, benefits, and potential consequences of the Essure device to patients. In light of recent developments, and the new evidence brought forth in the form of women’s personal accounts after using this device, the National Women’s Health Network believes that Bayer should revise the patient information guide and sponsor a national registry of women who received the Essure implant.

The personal and incredibly brave testimony of the women speaking here today should not be dismissed simply because it did not result from a clinical trial. Research scientists, the medical community, and health advocates acknowledge that randomized clinical trials are the gold standard for evidence-based research. We also recognize that it is not always realistic to ask women to be randomized to contraceptive methods and procedures. The evidence we have available right now about Essure are after-the-fact studies, with all of their limitations, and the lived experiences of women, as reported by women themselves. Women’s reports of pelvic pain, as well as the other frequently reported adverse effects such as autoimmune and mood disorders, should be taken very seriously.

Though not currently on the prescriber or patient label, the experiences of women who have suffered negative health events after receiving the implant should be made available to other women considering the Essure implant. Women considering using this device deserve to know this information. No woman should be forced to learn after the fact that more information was available and that it would have affected her decision to take a particular drug or use a certain medical device.

The Network also supports a change in the labeling and patient information guide for the Essure implant. Currently, under the “Risks: Long Term” section on the patient information guide, there are only two bolded statements explaining possible long term adverse effects. Below this section, a paragraph should be added explaining that women have experienced an array of adverse health effects after receiving the Essure device. The section should explain that while these effects were not revealed during the clinical trials, the information was added in order to be transparent about women’s experiences with this product.

Furthermore, we support taking patient labeling one step further and requiring that women receive written information about the device prior to implantation. The FDA should use all resources in their power to make knowledge sharing of women’s experiences possible and real.

The National Women’s Health Network recognizes and appreciates the suffering of the women testifying today. Our hope is for a future where women considering Essure will have access to the full range of information necessary to make an informed decision. To this end, we support the creation of a national registry to serve as a central database for women who have received the Essure implant. This registry would be funded by Bayer Pharmaceuticals and administered by a third party vendor. The purpose of this database is to make sure that all women with Essure are followed and that data collection and analysis is not controlled by the sponsor.

In 2002, the National Women’s Health Network supported the approval of Essure in light of the need for expanded contraceptive choice and the desirability of making sterilization safer. We stated that if Essure was appropriately incorporated into the array of contraceptive options offered to women and adequately studied post-approval, it had the potential to advance women’s health. We stand behind that statement today. To continue improving the lives of women, the FDA should listen to the women testifying and require the creation of a national registry and changes to the patient information guide.

Ignoring the voices of the women standing before you today leaves out women’s experiences that do not fit the narrative the pharmaceutical industry wishes to tell. The physical and emotional effects these women have suffered since their Essure implant are real. Their stories and their voices deserve to be heard and respected. Thank you.